UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effect of intake of ingredients derived from animal on cognitive functions
Title of the study (Brief title)	A study for the effect of intake of ingredients derived from animal on cognitive functions
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of ingredients derived from animal on cognitive functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tests for memory functions
Key secondary outcomes	Tests for memory functions Tests for attention functions Tests for executive functions Tests for mental status Questionnaires

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of food containing ingredients derived from animal, 6 tablets a day, 12 weeks
Interventions/Control_2	Intake of placebo 6 tablets a day, 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Men and women aged from 45 to 64 2)Subjects whose primary language is Japanese 3)Subjects with self-awareness of forgetfulness, especially who often forget the name of people, or objects 4)Subjects who often carelessly make mistakes in daily life 5)Subjects with inferior scores of primary outcome
Key exclusion criteria	1)Subjects who have difficulties in recognition of colors 2)Subjects whose visual or hearing acuity is too low to perform tests, or who have been diagnosed as amblyopia, blindness, or deafness 3)Subjects whose score of the HDS-R is less than 20 4)Subjects who have anamnesis of cranial nerve disease 5)Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder 6)Subjects who are being treated with hormone, or who have been diagnosed as menopausal symptoms 7)Subjects who sometimes have irregular lifestyles during the study 8)Heavy drinkers 9)Smokers or subjects who started smoking cessation within 12 months 10)Subjects who have taken the similar cognitive function tests within 12 months 11)Subjects who are being treated for cognitive functions, or who are prescribed drugs associated with cognitive functions 12)Subjects who regularly take drugs or health foods which may affect cognitive functions more than once a week 13)Subjects who regularly take foods similar to test foods more than once a week 14)Subjects who regularly take energy drinks more than once a week 15)Subjects who have done blood transfusion or blood donation within 3 months 16)Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study 17)Subjects who have diseases requiring regular administration, or who have severe diseases 18)Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value 19)Subjects who may have physical deconditioning due to test foods 20)Subjects who are, or are planning to be pregnant or breastfeeding during study 21)Subjects who are judged as unsuitable due to lifestyle questionnaire 22)Subjects who and whose family work in a company developing functional foods 23)Subjects who are judged as unsuitable by doctor for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	Kuniaki Obara
Organization	Kirin company, Limited
Division name	Research and Development division, Research Laboratories for Health Science & Food Technologies
Address	1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL	080-1930-9932
Email	k-obara@kirin.co.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	Kirin company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 05 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031672